You may have seen “food-grade” and “pharmaceutical-grade” designations for walk in coolers and freezers, but do you know what these qualifications mean to your business?
While food-grade and pharmaceutical-grade cold storage solutions both prevent spoilage of sensitive products, they can have very different standards, regulations, and methods of operation. Understanding what each one is designed for can help you make the right choice for your application, whether it’s for temporary fluctuations in inventory, emergency storage during an equipment failure, or onsite cold storage for events.
Food-grade cold storage: flexible, reliable, and scalable
Food-grade walk in coolers and freezers focus on keeping foods fresh, preventing contamination, and ensuring consistent temperatures for a wide range of food categories. They are subject to and designed to meet USDA and FDA standards for the safe handling of perishable goods.
Food-grade cold storage features include:
Temperature control within a range
Adjustable settings for chilled (≈ 33–41 °F / 1–5 °C) and frozen (-10–0 °F / -23–-18 °C) storage, with systems designed for quick return to setpoint after door openings.
Sanitary surfaces
The FDA requires food-grade walk in coolers and freezers to have interior surfaces that are “smooth, non-absorbent, resistant to moisture and easy to sanitize” for quick cleaning and preventing growth of mold and bacteria.
Large capacity
Designed for industries that move a high volume of products quickly, such as meat processors, or those who need access to a wide range of products, such as restaurants and caterers.
Operational practicality
Compatible with sheet pans, carts, mobile racks. Some units are compatible with pallets and optional ramps.
Versatility and scalability
Food-grade walk in cold storage units allow manufacturers and catering companies to scale up quickly for harvest peaks, holiday surges, or inventory overflow.
Pharmaceutical-grade cold storage: precise and compliant
Because even short excursions outside of specific temperature ranges can cause sensitive pharmaceuticals to degrade, the FDA, CDC, WHO, and other agencies have created stringent federal and global regulations to ensure that vaccines, biologics, specialty drugs, and other delicate products are constantly maintained within precise ranges.
Pharmaceutical cold storage features include:
Precise temperature control
Engineered for narrow setpoints (e.g. +2 to +8 °C for refrigerated or –20 °C for deep frozen) with tight tolerances of ±1 °C and rapid return to setpoint after door openings to maintain product stability.
Continuous visibility
24/7 monitored alarms for temperature, power, and door openings. Audit trails for acknowledgements and resolution.
Documentation & qualification
Uniformity mapping, IQ/OQ/PQ support, calibration certificates, and continuous data logging with electronic records suitable for audits (e.g., 21 CFR Part 11 when required).
Risk mitigation
Power/temperature redundancy strategies, alarm escalation procedures, and plans for managing temperature deviations.
Pharmaceutical-grade storage is not only responsible for keeping pharmaceutical products cold. It must also maintain tight temperature tolerances to ensure their stability and safety throughout the supply chain.
Quick Comparison Chart
| Dimension | Food-grade cold storage | Pharmaceutical-grade cold storage |
| Primary objective | Safe, sanitary holding for food with good temperature stability | Tight control and traceability to protect sensitive products and achieve compliance |
| Typical setpoints/tolerances (examples) | Chilled ≈ 34–41 °F (1–5 °C) with tolerances ±2–3 °C.
Frozen (≤ 0 °F / –18 °C) with tolerances ±2–5 °C |
Examples include +2 to +8 °C, –20 °C with tight tolerances of ±1 °C |
| Temperature performance | Stable operation suitable for frequent door openings and high throughput | Tight tolerances with heat-load planning, uniformity mapping, and minimized excursions |
| Monitoring & alarms | Onboard thermostats, optional data logging | Calibrated sensors, continuous data logging, and 24/7 alarms for out-of-range, power, and door |
| Data & documentation | Sanitation-focused cleaning and maintenance logs | IQ/OQ/PQ packages, calibration certificates, electronic records (e.g., 21 CFR Part 11 when applicable) |
| Surfaces & sanitation | Smooth, non-absorbent, moisture-resistant, easy to clean | Same as food-grade plus construction and documentation as required for qualification and audits |
| Redundancy & risk mitigation | Practical for food safety and operations | Power and temperature redundancy strategies, alarm recipient lists, and deviation handling |
| Standards & guidance (examples) | Food safety codes/standards (e.g., FDA Food Code, USDA contexts, NSF/ANSI sanitation) | cGMP/GDP expectations, USP <1079> storage/distribution guidance, CFR/Part 11 for e-records (where applicable) |
Choosing between food- or pharmaceutical- grade cold storage
Choosing between food- and pharmaceutical-grade cold storage may be simple for some companies, but if your products aren’t easily classified as one or the other, use the following questions, adding or subtracting a point (as indicated) for each “yes” answer:
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If your score was 3 or higher, you most likely need pharmaceutical-grade cold storage.
Polar Leasing: the best choice for food- and pharmaceutical-grade cold storage
At Polar Leasing, we have the largest fleet of food- and pharmaceutical-grade walk-in cooler and freezer rentals in North America, standing by to ship from our distribution centers nationwide.
Whether you need temporary cold storage during an equipment failure or event or if you need to quickly increase capacity to meet demand, we have the food-grade and pre-validated pharmaceutical grade temporary cold storage you’ve been looking for.
With a wide variety of portable walk-in cold storage units readily available, Polar Leasing helps manufacturers quickly increase capacity without sacrificing safety or compliance.
Polar Leasing’s Fiberglass Advantage
Wondering how Polar Leasing maintains such tight temperature tolerances? The secret is in our patented construction process. Each unit features thick polyisocyanurate rigid board insulation encapsulated in durable, seamless fiberglass. This creates an extremely rugged, one-piece structure without the “hot spots” common to walk-ins with foamed-in insulation.
- Creates a seamless surface inside and out without cracks or crevices where bacteria can accumulate.
- Makes food- and pharmaceutical grade cold storage units easy to sanitize.
- Minimizes heat exchange, making Polar Leasing units the most energy-efficient temporary walk in cooler and freezer rentals on the market.
Pre-validated pharmaceutical-grade cold storage rentals
Our pharmaceutical-grade temporary walk in coolers and freezers undergo rigorous validation testing before they leave the factory. We also provide comprehensive documentation to support the onsite validation process.
Redundancy and remote monitoring
We offer systems with dual compressors and partner with Rastrac for tracking a range of data points, including:
- real-time temperature
- door openings/closings
- defrost cycles
We use this information for troubleshooting and have also provided it to customers who needed to fill in lapses in monitoring data.
Polar Leasing: your food- and pharmaceutical-grade cold storage partner
Whether you need temporary cold storage for foods, pharmaceuticals, or any other temperature-sensitive products, you can count on the expert team at Polar Leasing for the solutions and guidance you need to keep your products safe and in compliance with industry regulations.
Contact us today and find out why more businesses choose Polar Leasing than any other temporary cold storage company.
Contact UsFAQ
What qualifies as pharmaceutical-grade cold storage?
Although some manufacturers label all walk in freezer or cooler rental units with tight temperature tolerances as “pharmaceutical grade”, they may not meet the documentation requirements or performance demands required to store pharmaceutical products. If you’re storing highly regulated products, be sure that your walk in coolers and/or freezers deliver tight temperature control (typically ±1 °C) with documented uniformity, have calibrated sensors, continuous logging, and 24/7 alarms, and are supported by documentation suitable for audit.
Do I need continuous monitoring for vaccines and investigational products?
Because even short excursions outside the specified range can compromise the efficacy or safety of sensitive products, most programs require continuous data logging, calibrated probes, alarms, and documented responses to any excursion.
Can food-grade units ever be used for nutraceuticals or supplements?
Some nutraceuticals and supplements have wider tolerances than others, so select programs may not require qualification, alarms, or audit-ready records. Verify the storage requirements with the manufacturer or sponsor of your products before choosing your cold storage solution.
What documentation should I expect with a pharmaceutical-grade rental?
Provided documentation with a pharmaceutical-grade walk in cooler or freezer rental may include:
- Calibration and performance documentation for validation support
- Insulation and equipment installation inspection
- Empty unit open door temperature recovery testing
- Empty unit power failure testing
- 24-hr empty unit thermal mapping
- User manuals and SOPs
- Access to electronic data and alarm histories (when required).
Ask your rental provider what documentation they provide before choosing your solution.
Can a food-grade unit be upgraded to meet pharmaceutical expectations?
You can add monitoring, alarms, and procedures, but without demonstrated uniformity, calibration, and qualification records, it is not likely to meet pharmaceutical requirements. Pharmaceutical-grade units were purpose built from the beginning with high-performance in mind. If you need those elements, select a pharmaceutical-grade unit.
